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Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.
Full description
A patient population with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, in lesions measuring 3 to 12cm in length, will be treated with radiofrequency ablation (RFA) using the HALO ablation system. Additional RFA sessions will be performed on 3 month intervals until complete response (CR; no MGIN or worse in biopsies) will be achieved. All patients will then undergo an endoscopy at 12 months after baseline. Patients with CR at 12 months will be followed-up for 5 years with annual endoscopy and biopsies, and additional treatment if necessary. Patients with no CR at 12 months are considered failures.
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Inclusion criteria
Subject is 18-80 years of age, inclusive
Subject meets at least one of the following inclusion criteria:
On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and has MGIN or worse (MGIN+) on biopsy
The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
Baseline EUS (all patients) shows no exclusionary findings for the trial
CT scan of chest and upper third of the abdomen (all HGIN and SCCA patients) shows no exclusionary findings for the trial
Subject is not pregnant nor has plans to become pregnant in the ensuing 12 months (confirmation of non-pregnant status in women of child-bearing age and ability required with urine or blood test)
Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol
The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation
Exclusion criteria
the Eligibility CRF.
Primary purpose
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Interventional model
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96 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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